Pfizer Inc. and Eli Lilly and Company have held out hope for approval of their first-in-class nerve growth inhibitor tanezumab in a substantial commercial market despite a serious risk profile that put the clinical trial program on hold and later led it to be scaled back. If tanezumab could win US Food and Drug Administration approval in osteoarthritis pain, where the risk appeared greatest, the companies believed label expansions could follow.
However, a near-term US approval of the biologics license application for osteoarthritis appears unlikely after the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee took a largely negative view of the risk/benefit profile of tanezumab over a two-day meeting on 24 and 25 March
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